The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Kawasumi Laboratories K-cuff.
| Device ID | K930012 |
| 510k Number | K930012 |
| Device Name: | KAWASUMI LABORATORIES K-CUFF |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
| Contact | Shozo Moriyama |
| Correspondent | Shozo Moriyama KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-04 |
| Decision Date | 1993-12-14 |